MR Na/K Check Solution

Basic Information

• Brand Name: MR Na/K Check Solution
• Primary DI: 06936415904661
• Version / Model: 105-011386-00
• Company Name: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
• Labeler DUNS: 654671304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-01-23
• Public Version: 1
• Public Version Date: 2026-02-02
• Public Version Status: New
• Public Device Record Key: 520f9fbf-5e90-4d9f-9b8b-369fdbc77500

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52892	Potassium (K+) IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of potassium (K+) in a clinical specimen, using an ion-selective electrode (ISE) method.	No	Active
52896	Sodium (Na+) IVD, kit, ion-selective electrode (ISE)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of sodium (Na+) in a clinical specimen, using an ion-selective electrode (ISE) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06936415904661	GS1

Premarket Submissions

Submission Number	Supplement Number
K160370	000